New Power Morcellator Lawsuits Are Filed Regularly
Several power morcellator manufacturers are facing a growing number of lawsuits after the FDA published a safety warning.As word spreads of the U.S. Food and Drug Administration safety warning regarding the use of power morcellators during gynecological procedures, numerous women and their families have come forward and filed lawsuits against several morcellator manufacturing companies.
The FDA Safety Warning
On April 17th, 2014, the FDA released a safety warning which informed the medical community and public that research suggested the use of a power morcellator during hysterectomies and myomectomies could potentially spread undiagnosed uterine cancer. This came as a shock to surgeons who had been using the morcellator for decades.
Researchers determined that when the morcellator was used to cut through tissue the cutting jaws also disseminated cells throughout the body cavity. If cancer cells are disseminated to other organs, they may take root and result in metastases that otherwise would not have occurred.
Current Morcellator Lawsuits
At this time, 30 lawsuits have been filed against manufacturers such as Ethicon, Karl Storz, Richard Wolf GmbH, and Gyrus ACMI. Each lawsuit alleges that a women who underwent a gynecological laparoscopic surgery had undetected uterine cancer which was upstaged by the use of a morcellator.
The majority of these lawsuits name a type of cancer called a leiomyosarcoma which is difficult to treat. Each plaintiff has undergone aggressive chemotherapy and radiation treatments. Sadly, several of the plaintiffs have passed away despite the treatment.
Ethicon Withdraws Morcellators From The Market
Shortly after the FDA safety warning, one of the biggest morcellator manufacturers, Ethicon announced that it was voluntarily withdrawing all of its morcellators from the market. The company also sent a letter globally to all doctors that had bought a product urging them to stop using the tool.
The letter stated that “We believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain. Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon Morcellation Devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.”
At this time, none of the other manufacturing companies has withdrawn their products.